Archive for category FDA

Rumors regarding the development of a ‘digital pill’ with a microchip inside have been circulating for some time, but today, the FDA actually green lighted the product.

The company, Proteus Digital Health, gained FDA approval for its 1 square millimeter device (the size of a grain of sand), which it believes will “shift the care paradigm” into an era of digital medicine.

According to Proteus Digital Health’s website:

Digital Medicines are the same pharmaceuticals you take today, with one small change: each pill also contains a tiny sensor that can communicate, via our digital health feedback system, vital information about your medication-taking behaviors and how your body is responding.

The company added “As a result, you can be sure you’re taking your medicines as prescribed, while at the same time receiving unprecedented feedback on your physical response to treatment.”

The aim of the “ingestible sensor” is to electronically verify patient compliance in taking the medication.

Some excitingly call it the ‘beginning of an era in digital medicine,’ while others view it as a technological movement toward absolute lunacy – despite the positive-sounding advancements. Scientists are moving to put digestible microchips inside of prescription drugs so that your doctor knows if you’re actually taking your medication or not.

Doctors Could Monitor You with Digital Pills

How exactly could these microchips track your medication consumption? The sensor, which is about the size of a grain of sand, generates a voltage in response to digestive juices. The voltage response ultimately transfers a signal to the skins surface, where a patch worn by the person then sends the information to a doctor’s phone.

Although the sensors within the microchip are the first digestible devices actually approved by the FDA, the approval is only based on studies using placebo pills that show it’s safety and efficacy. Of course, digestible microchip creator Proteus would love nothing more than to have the device approved for the massive amounts of pharmaceutical drugs given out today – many of which are taken for a lifetime.

“About half of all people don’t take medications like they’re supposed to. This device could be a solution to that problem, so that doctors can know when to rev up a patient’s medication adherence,” said Eric Topol, director of the Scripps Translational Science Institute in La Jolla,California. While Topol isn’t affiliated with Proteus Digital Health, the company that manufactures the futuristic device, he embraces what it has to offer, and says“It’s like big brother watching you take your medicine.”

Recent research and data are challenging long held beliefs about the benefits of pasteurization, and a vigorous debate is currently underway in the medical profession over the safety and benefits of raw, organic dairy products.

Whatever side of this argument any individual comes down on in the scientific debate, the policy and law that comes out of that debate has to be seen in the larger societal and historical context. If farmers have enjoyed the freedom to grow and process their foods as they see fit for centuries, and customers likewise have enjoyed the freedom to purchase those foods from those producers they personally trust, how and why did the FDA gain the authority to interfere in that process? By what jurisdiction does a federal regulator have the authority to legislate what foods people are allowed to put into their own bodies?

Nanotechnology is measured in billionths of a meter, encompassing all aspects of life from food to medicine, clothing, to space. Imagine hundreds of microcomputers on the width of a strand of hair programmed for specific tasks….in your body. Sound good?

Engineering at a molecular level may be a future corporations’ dream come true, however, nano-particles inside your body have few long-term studies especially when linked to health issues. Despite this new huge income-generating field there is a growing body of toxicological information suggesting that nanotechnology when consumed can cause brain damage (as shown in largemouth bass), and therefore should undergo a full safety assessment.

It is possible for nano-particles to slip through the skin, suggestive of a potential unnatural interaction with the immune system, or when micro particles enter the blood-stream. Some sunscreens on the shelf today, for instance, have nano-particles that might be able to penetrate the skin, move between organs, with unknown health effects. Nano-particles in cosmetics have few regulations done by FDA.

What do latchkey kids, college students, and busy parents have in common? Well, one thing is that they save valuable time and money by cooking with canned foods. The bad news? Tagging along with these foods is a hefty dose of bisphenol A.

According to a past study conducted by the nonprofit Consumers Union, 18 of 19 canned foods contained 22 micrograms of BPA per serving—116 times more than the ‘daily recommended limit.’ Progresso, Del Monte, Campbell’s, Annie’s, and Hormel soups took the BPA lead. Unfortunately, BPA still continues to taint food cans today.

BPA Affects Fertility

Researchers have linked BPA consumption to hyperactivity, aggression, depression, obesity, diabetes, heart disease, various cancers, and reproductive difficulties including Anogenital distance. Males with short AGD have been found to have 7 times the chance of being sub-fertile. This is a troubling statistic given that prenatal BPA exposure through parental consumption is associated with shortened AGD.

Men alone are not at risk, however. The journal Human Reproduction published a study that found women who miscarried three or more times had markedly high levels of BPA compared to mothers of successful pregnancies.

Food Industry’s Ties to BPA

That the food industry has remained largely silent despite this barrage of research means one thing: they’re making too much money to change. As said by the Natural Resources Defense Council, the FDA has repeatedly failed “to safeguard the food supply.” Even the Environmental Protection Agency left BPA off the list of chemicals needing stricter regulation after a heart-to-heart with lobbyists.

Though even while, until now, both companies and manufacturers have been slow to remove BPA, the chemical is slowing inching it’s way out of food and consumer products. One most recent decision was made by the FDA to ban BPA in baby bottles. But even with BPAs departure, companies are beginning to use a close relative of BPA known as bisphenol-S. Unfortunately, this BPS chemical is also toxic.

Staying BPA-Free

Still, there’s no need to despair. Just because the industry isn’t on the side of healthful eating doesn’t mean we can’t enjoy the convenience of canned foods. Eden Foods lines most of its cans with oleoresin (a plant-based lining) and puts acidic foods like tomatoes in paper cartons often used for soups.

You can even DIY canned foods with a home canning kit and BPA-free lids. Parents wary of BPA’s effects on their children’s health as well as their future fertility can even make canning a family venture, with benefits to be reaped for months!

About two-thirds of women in the United States take one or more prescription medications during pregnancy, many of which the potential effects on a fetus are unclear. In developed countries, birth defects are the leading cause of infant mortality. The complex melange of factors that contribute to a healthy pregnancy make it very difficult to specifically identify causal factors, but it is widely agreed upon that taking medication during pregnancy can result in fetal damage.

Use of Medication During Pregnancy a Dangerous Decision

In 1979, the United States Food and Drug Administration introduced a system to classify pharmaceuticals based on fetal risks. The two highest categories of risk in this system are ‘Category X,’ where fetal abnormalities could occur, and/or there is positive evidence of human fetal risk based on adverse reaction data, and the risks involved in the use of medication during pregnancy clearly outweigh potential benefits. Then there is ‘Category D,’ where it is claimed that the use of the drug will provide more benefits than risks, despite positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans. Needless to say, pharmaceutical drugs should be avoided, especially while pregnant.

An analysis of almost 13,000 doctor visits made by women of childbearing age between 1998-2000 showed that one out of every thirteen was on a class D or X medication, and given the steep and steady increase in prescriptions for psychotropic drugs in the past decades, it’s likely that this number is also increasing.

In addition to these medications which are known to pose a risk, the data on many other prescription drugs is limited at best. According to Dr. Cheryl Broussard, Epidemiologist with the Centers for Disease Control and Prevention, most medications have not been adequately evaluated for use during pregnancy, and one study showed that more than 90% of medications approved by the US Food and Drug Administration (FDA) from 1980 to 2000 had insufficient data to determine the risk in human pregnancy.

[NaturalNews] In the aftermath of the Aurora, Colorado Batman movie theater shooting, President Obama chimed in on the gun control debate yesterday, saying, “Every day, the number of young people we lose to violence is about the same as the number of people we lost in that movie theater. For every Columbine or Virginia Tech, there are dozens gunned down on the streets of Chicago or Atlanta…” (http://www.washingtontimes.com/news/2012/jul/25/obama-calls-measures-…)
What he didn’t say, however, is that every day 290 people are killed by FDA-approved prescription drugs, and that’s the conservative number published by the Journal of the American Medical Association.

As no one seems to believe these numbers are real, I’ll quote the source: The Journal of the American Medical Association (JAMA) Vol 284, No 4, July 26th 2000, authored by Dr Barbara Starfield, MD, MPH, of the Johns Hopkins School of Hygiene and Public Health.

That study, which is twelve years old — and drug deaths have risen considerably since then — documents 106,000 deaths per year from the “adverse effects” of FDA-approved prescription medications.

To reach this number from outbreaks of violent shootings, you’d have to see an Aurora Colorado Batman movie massacre take place every HOUR of every day, 365 days a year.

If a massacre of people using slugs of lead is bad, why is a massacre of people using deadly chemicals perfectly acceptable?

A medical massacre that dwarfs the number of deaths from shootings

No one in Washington talks about prescription drug deaths. There are no sobbing victims shown on the evening news. This “chemical massacre” happens quietly, behind closed doors. Yet to achieve this level of mass death in the world of plane crashes, for example, you’d have to see a jumbo jet airliner crashing into the ground once a day, every day of the year.

But that’s only the beginning of the mass death caused by modern medicine, where greed-driven doctors are routinely bribed by the drug giants (http://www.naturalnews.com/036510_doctors_bribes_drug_companies.html) and thereby make the “Joker” James Holmes look like a boy scout by comparison. As NaturalNews previously revealed, just one company — GlaxoSmithKline — had a bribery network of 49,000 doctors who received financial kickbacks to prescribe more Glaxo pharmaceuticals to patients.

The bottom line total comes to 783,936 deaths every year from “conventional” medicine (drugs and surgery medicine).

You are 6200% more likely to be killed by your doctor than by a shooter

According to the CDC’s numbers from 2007, the total number of homicide shooting deaths in the United States each year is roughly 12,600 (Xu, Jiaquan; Kenneth D. Kochanek, Sherry L. Murphy, Betzaida Tejada-Vera (2010-05-20). “Deaths: Final Data for 2007” (PDF). National Vital Statistics Reports (CDC) 58(19): 11. Retrieved 2011-04-07.)

This means that your risk of being killed by your doctor is 62 times higher than the risk of being killed by a shooter. Put another way, that’s a 6200% higher risk.

It seems that before we even think about the issue of gun control, we need a national debate on DOCTOR control.

After all, when doctors inadvertently kill people by prescribing deadly chemotherapy cocktails or deadly prescription drugs, they don’t even get arrested for it! But they do get financial kickbacks, exotic vacations paid by drug companies, free travel, free meals and other perks of being a Big Pharma whore. Plus, they’re free to go on killing other people, over and over again. While doctors obviously don’t intend to kill people, they nonetheless keep doing so as long as they get their bribes, kickbacks and perks. (http://www.naturalnews.com/036417_Glaxo_Merck_fraud.html)

If Obama really wanted to protect Americans from being killed, he’d call for restrictions on the prescribing of deadly pharmaceuticals. But don’t hold your breath on that one, because when it comes to actually protecting the American people from medical massacres, or GMOs, or toxic fluoride in the water supply, the real Joker is Obama himself.